Thursday, September 15, 2022 8:55:49 PM
Joendoeuk, the authors of the NYAS presentation mentioned that the most likely reason for the 6.2 months mPFS of the treatment patients and the 7.6 months mPFS of the ECAs was that pseudoprogression in the treatment group was recorded as true progression. Given that the treatment group had an mOS which was 2.5 month longer than the mOS of the placebos (19.3 months vs. 16.8 months), this explanation seems very logical. If the mPFS of the treatment group had nothing to do with pseudoprogression, the median survival of this group after progression would have equaled 13.1 months (19.3-6.2=13.1) whereas the median survival time of the placebos after mPFS would have only been 9.2 months ( 16.8-7.6=9.2) which would have constituted an even greater advantage for the treatment group.
Furthermore, the 23.1 months from surgery refers to the mOS of the entire trial of 331 patients or to the first half of the trial (the first 165-166 patients) and not to the mOS of the placebos. The mOS of the 232 patient treatment group is only about 22.4 months from surgery (19.3 months from randomization) because the remaining group of 99 patients have a considerably longer mOS than the treatment group.
Since the 35 placebos in that group of 99 have a very short mOS (less than 12 months), the 64 crossover group has unquestionably, the longest mOS in this trial and constitutes therefore a very pleasant surprise
Furthermore, the 23.1 months from surgery refers to the mOS of the entire trial of 331 patients or to the first half of the trial (the first 165-166 patients) and not to the mOS of the placebos. The mOS of the 232 patient treatment group is only about 22.4 months from surgery (19.3 months from randomization) because the remaining group of 99 patients have a considerably longer mOS than the treatment group.
Since the 35 placebos in that group of 99 have a very short mOS (less than 12 months), the 64 crossover group has unquestionably, the longest mOS in this trial and constitutes therefore a very pleasant surprise
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